{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2013-04869", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110801", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "563127", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250826", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20131101", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "36 YR", "patient_sex": "", "patient_weight": "86", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pulmonary Embolism", "Abdominal Pain", "Abscess", "Purulent Discharge", "Fistula", "Micturition Urgency", "Hemorrhage/Blood Loss/Bleeding", "Tachycardia", "Urinary Tract Infection", "Vomiting", "Malaise", "Abdominal Cramps", "Fluid Discharge", "Test Result" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3442729", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131002", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "3949328", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR MENORRHAGIA ON (B)(6) 2011 INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE FIBROID UTERUS WAS 732 GRAMS AND 14CM, TAKING UP THE ENTIRE PELVIS LEAVING LITTLE ROOM TO WORK ON EITHER SIDE. INSTRUMENTS WERE USED TO CREATE TISSUE TENSION, WHICH ALLOWED THE PERFORMANCE OF THE SURGERY. BLUNT CAUTERY AND SHARP DISSECTION WAS USED TO DISSECT THE BLADDER OFF OF THE ANTERIOR ASPECT OF THE UTERUS AND CERVIX, AND 1CM AROUND THE VAGINA. ENCOUNTERED UTERINE VESSELS WERE VERY THICK AND REQUIRED MULTIPLE CAUTERIZATIONS AND DIVISION. IT WAS NOT POSSIBLE TO ANTEFLEX THE UTERUS DUE TO ITS SIZE. BOTH URETERS WERE VISIBLE AND KEPT IN VIEW WHILE ALL CAUTERY AND DISSECTIONS WERE PERFORMED. EXCELLENT HEMOSTASIS WAS NOTED UPON VAGINAL CUFF CLOSURE. INDIGO CARMINE WAS ADMINISTERED FOR URETER VISUALIZATION AND GOOD FUNCTION WAS OBSERVED. THE ESTIMATED BLOOD LOSS FROM THE PROCEDURE WAS 200ML. NO CONCERNS ABOUT BOWEL INTEGRITY WERE NOTED DURING THE SURGERY. SHE WAS DISCHARGED THE FOLLOWING DAY, ON (B)(6). ON (B)(6) 2011, THE PATIENT PRESENTED TO THE ER WITH VOMITING AND ABDOMINAL PAIN CONSISTENT WITH ILEUS. SHE WAS OBSERVED AND SENT HOME THAT DAY, RETURNING TO THE OFFICE ON (B)(6) FOR FOLEY CATHETER REMOVAL. THAT EVENING SHE EXPERIENCED MALAISE, MULTIPLE EPISODES OF BLADDER EMPTYING, PROFUSE WATERY DISCHARGE AND CRAMPY PAIN AND PRESENTED TO THE ER ON THE ADVICE OF HER PHYSICIAN. VAGINAL EXAMINATION REVEALED AN INTACT VAGINAL CUFF, ALTHOUGH PRESSURE BEHIND THE CUFF WAS WORRISOME FOR CUFF CELLULITIS, HEMATOMA OR POTENTIAL ABSCESS. PURULENT BLOODY DISCHARGE WAS PRESENT. A CT SCAN SHOWED A 6CM PELVIC ABSCESS ON THE RIGHT SIDE AND FLUID COLLECTION ON THE VAGINAL CUFF. THE PELVIC ABSCESS WAS FELT TO BE PRESSING ON HER RIGHT URETER CAUSING HYDROURETER AND HYDRONEPHROSIS. URINALYSIS UNREMARKABLE BUT WBC COUNT HIGH. ON (B)(6) 2011, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FOUND TO BE TACHYCARDIC AND BROUGHT TO THE ER FOR PULMONARY EMBOLISM EVALUATION. MENTION OF PRIOR PLACEMENT OF A RIGHT SIDE NEPHROSTOMY TUBE ON (B)(6) OCCURS IN THIS HISTORY, BUT NO OTHER RECORD OF SUCH TUBE PLACEMENT IS PROVIDED. A CT SCAN CONFIRMED LARGE, BILATERAL PULMONARY EMBOLI AND SHE WAS ADMITTED. O2 SAT 96%. URINALYSIS SHOWED RED AND WHITE BLOOD CELLS, AND WBC RETURNED TO NORMAL IN CBC. SHE WAS DISCHARGED ON (B)(6) 2011 IN STABLE CONDITION AND PLACED ON ANTICOAGULANTS. RECONSTRUCTION OF THE URETER WAS PUT OFF FOR AT LEAST 6 MONTHS DUE TO HER NEED FOR ANTICOAGULATION THERAPY. ON (B)(6)2012, THE PATIENT UNDERWENT A LAPAROTOMY FOR A RIGHT URETERAL REIMPLANT AND A VESICOVAGINAL FISTULA REPAIR WITH PERITONEAL FLAP. A RIGHT 6 FR JJ STENT WAS PLACED VIA CYSTOSCOPY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT PRESENTED WITH A URINARY TRACT INFECTION IN AN OFFICE VISIT. AN ABNORMAL URINALYSIS WAS MENTIONED IN A NARRATIVE BUT NO REPORT WAS PROVIDED. A URINALYSIS WAS REPEATED AND WAS NORMAL. THE PATIENT CONTINUES TO EXPERIENCE URINARY ISSUES SUCH AS UTIS AND URGENCY AN OFFICE VISIT REPORT IS PROVIDED FOR (B)(6) 2012. NO SUBSEQUENT INFORMATION IS PROVIDED AFTER THIS REPORT." }, { "mdr_text_key": "11373875", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL PROCEDURE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }